# K982846: MTEK-1400

- Pathway: 510(k) (Traditional)
- Applicant: Magna Advanced Technologies, Inc.
- Decided: Sep 18, 1998 after 37 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MTEK-1400 unit is.to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient’s cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEK-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate. Federal Law restricts the use of this device by or on the order of a qualified physician ouly.

Source page: https://510kreport.com/device/K982846
Methodology: https://510kreport.com/methodology